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Supplement Amino Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01540773
First received: February 23, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.


Condition Intervention
Growth Hormone
Amino Acid
Drug: Amino acid supplement
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Growth Hormone 120 Minutes Following a Single Low-dose of Amino Acids in Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Quantity of Growth Hormone [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    Measure human growth hormone at times -30, -15, 0, 30, 60, 90, and 120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.


Secondary Outcome Measures:
  • Insulin-like growth factor 1 [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    Measure IGF-1 eight hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebos.


Enrollment: 19
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amino acid supplement
supplements with the proprietary amino acid derivative blend.
Drug: Amino acid supplement
An orally administered supplement of the proprietary amino acid derivative
Placebo Comparator: Placebo
Non-Active
Drug: Placebo
A non-active orally administered supplement of the proprietary amino acid derivative

Detailed Description:

Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 healthy males and 4 healthy females
  • Between 18 and 70 years

Exclusion Criteria:

  • Pregnant or nursing
  • Taking any chronic medication including birth control pills.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540773

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01540773     History of Changes
Other Study ID Numbers: PBRC10043
Study First Received: February 23, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
growth hormone

ClinicalTrials.gov processed this record on November 20, 2014